JP2021500162A - 事前接続された分析物センサ - Google Patents
事前接続された分析物センサ Download PDFInfo
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- JP2021500162A JP2021500162A JP2020522951A JP2020522951A JP2021500162A JP 2021500162 A JP2021500162 A JP 2021500162A JP 2020522951 A JP2020522951 A JP 2020522951A JP 2020522951 A JP2020522951 A JP 2020522951A JP 2021500162 A JP2021500162 A JP 2021500162A
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Abstract
Description
出願データシートで特定されたあらゆる全ての優先権主張、またはそれに対するいかなる修正も、米国特許法施行規則1.57の下で参照により本明細書に組み込まれる。本出願は、2017年10月24日に提出された米国仮特許出願第62/576,560号の利益を主張する。前述の出願は、参照によりその全体が本明細書に組み込まれ、本明細書の一部として明示的に作成される。
本明細書で説明される様々な実施形態の理解を容易にするために、いくつかの用語が以下で定義される。
グルコース+O2→グルコン酸+H2O2
生体内分析物検知技術は、生体内センサに依存し得る。生体内センサは、作用電極および参照電極などの1つ以上の電極を有する細長い導電性本体を含んでもよい。
図1は、いくつかの例示的な実装態様による例示的なシステム100を示している。システム100は、センサエレクトロニクス112および分析物センサ138を含む分析物センサシステム101を含む。システム100は、送薬ポンプ102およびグルコース計104などの他のデバイスおよび/またはセンサを含んでもよい。分析物センサ138は、センサエレクトロニクス112に物理的に接続されてもよく、センサエレクトロニクスと一体(例えば、取り外し不可能に取り付けられる)であっても、取り外し可能に取り付けられてもよい。例えば、連続分析物センサ138は、分析物センサ138をセンサエレクトロニクスと機械的および電気的にインターフェースするセンサキャリアを介してセンサエレクトロニクス112に接続されてもよい。センサエレクトロニクス112、送薬ポンプ102、および/またはグルコース計104は、ディスプレイデバイス114、116、118、および/または120などの1つ以上のデバイスと結合してもよい。
101 分析物センサシステム
102 送薬ポンプ
104 グルコース計
108 膜
112 センサエレクトロニクス
114、116、118、120 ディスプレイデバイス
126 接着パッチ
128 ハウジング
135 電子モジュール
138 分析物センサ
138a 遠位部分
138b 近位部分
139 ワイヤコア
141 スリーブ層
180 貫通孔
192 封止構造
1000、1000F、1002、1002F 接点
1410、1412 スロットまたは止まり穴
1420 貫通孔
1430 1432 追加の穴
1442、1444 止まり穴または窪み
1451、1453 プラグ
1500 導電性接着剤
1700 凹部
1800 第1の平坦部分
1802 第2の平坦部分
1900 凹部
202 アーム
205 特定用途向け集積回路(ASIC)
210 ポテンシオスタット
211 作用電極
211a 電極
211b 接点
212 参照電極
212a 電極
212b 接点
214 プロセッサモジュール
216 プログラムメモリ
218 メモリ
220 データ格納メモリ
222 ユーザインターフェース
224 ボタン
226 液晶ディスプレイ(LCD)
228 バイブレータ
230 オーディオトランスデューサ
232 遠隔測定モジュール
234 バッテリ
236 バッテリ充電器および/またはレギュレータ
237 入力ポート
238 通信ポート
239 出力ポート
2000 導電性テープ
2100 延長部分
2106、2108 ガイド構造
2200 導電性プラスチック部材
2300 超音波溶接ホーン
2600、2602 導電性取り付け部材
2700、2704 延長部分
2702 中央部分
2706、2708 導電性接点
2800 ベース部分
2802 折り畳み可能部分
2900 データム機構
2902 可動コネクタ
2906 導電材料
300 センサモジュール
306、306d コイルばね
308 突起
312、312d ベース部分
320バッテリ
320d 突起
322 演算増幅器
322d チャネル
324、334 接点
328 抵抗器
336 ガードトレース
358 遠位配向チャネル
3100 デバイス
3102、3104 導電性ブラケット
3200 可撓性基板の上部
3202 可撓性基板の下部
3204 ストリップセンサキャリア
3220 個片化機構
3300 ベース部分
3301 圧着コネクタ
3302 アーム
3404 可撓性回路ストリップ
3700 凹部
3702 導電性トレース
3704 接着剤
3720 フィンガーホールド
400 センサ
402 センサキャリア
404 基板
406 第1の内部接点
407 ガードトレース
408 第2の内部接点
409 ネットワーク
410 第1の外部接点
412 第2の外部接点
414 第1のトレース
416 第2のトレース
420 ガイド固定部
426 非導電性接着剤
428 感圧接着剤
430、432 データム機構
450 識別子
460 カバー
480 分析物センサのアレイ
490 クラウド型分析物プロセッサ
4000 基板
4001、4002 導電性ストリップ
4020 スコアリング
4300 開口部
4402 フィードガイドストリップ
4404 位置決め機構
4600 レセプタクル
4700 凹部
4800 基板
4802 処理部分
4804 センサ接続部分
4808 開口部
4860 パネル
500 電子ユニット
520 上部ハウジング
522 下部ハウジング
524、526 開口部
528、528a、528b 封止部材
530 エレクトロニクスアセンブリ基板
5002 試験ステーション
5004 較正ステーション
5006 レセプタクル
5008、5010 接点
5011 リーダ
5012 処理回路
5014 レセプタクル
5016、5018 接点
5020 処理回路
5022 接点
5024 空洞
5091 製造ステーション
5092 処理回路
5093、5095 把持構造
5094 機械構成要素
5100 メインプリント回路基板
5103 導電性取付機構
5104 接点
5200 ピンチクリップ
5202 圧着コネクタ
5204 アーム
5208 クラスプアーム
5220 電極ブレイクアウト
5300 導電性クリップ
5302 開口部
5304 導電性クリップの部分
5500 エラストマーチューブ
5501 開口部
5502 底部分
5503 切欠き
5504 接着剤
5530 基板
5531 装置
5700 ハウジング
5702 突出部材
5800 キャリア
5802 ハウジング
5804 インターフェース
5806 回路
5808 導電性接点
5810 キャリアを製造装置に機械的に結合するための1つ以上の構造
5812 摺動可能なバー
5814 ハンドル
5532、5534 接点
600 皮膚上センサアセンブリ
605 ベース壁
700、800 機械的レシーバ
702 レシーバ
704 接点
706、708 穴
712、714 導電性ピン
722、724 開口部
726 凹部
762、764 接続材料
766、768 壁
772 感圧接着剤
780 絶縁層
784、786 位置決めピン
794、796 穴 812、814 導電性パッド
820 フィルム
826、828 接点パッド
Claims (88)
- 装置であって、
分析物センサであって、
細長い本体と、
第1の導電性接点と電気的に連絡する第1の電極と、
第2の導電性接点と電気的に連絡する第2の電極と、を備える、分析物センサと、
前記分析物センサに取り付けられたセンサキャリアであって、
中間本体と、
前記中間本体上に配置された第1の導電性部分であって、前記第1の導電性接点と電気的に連絡する、第1の導電性部分と、
前記中間本体上に配置された第2の導電性部分であって、前記第2の導電性接点と電気的に連絡する、第2の導電性部分と、を含む、センサキャリアと、を備え、
前記第1および第2の導電性部分が、前記第1および第2の導電性接点と別個のデバイスとの間の電気的な連絡を確立するように構成された接続部分を形成する、装置。 - 前記中間本体に結合された識別子をさらに備える、請求項1に記載の装置。
- 前記識別子、前記センサ、および前記中間本体が、積層構成を形成する、請求項2に記載の装置。
- 前記識別子が、QRコードシートである、請求項2または3に記載の装置。
- 前記識別子が、光学識別子、無線周波数識別子、またはメモリ符号化識別子のうちのいずれかである、請求項2または3に記載の装置。
- 前記識別子が、前記分析物センサ、前記分析物センサの較正データ、および前記分析物センサの履歴のうちのいずれかを識別するように構成されている、請求項2または3に記載の装置。
- 前記第1の導電性部分および前記第2の導電性部分が、トレースである、請求項1〜6のいずれか一項に記載の装置。
- 前記トレースが、前記接続部分において露出した接触表面を形成する、請求項7に記載の装置。
- 前記第1および第2の導電性部分が、前記中間本体に少なくとも部分的に埋め込まれている、請求項1〜8のいずれか一項に記載の装置。
- 前記第1の導電性部分および前記第2の導電性部分が、はんだ溶接、導電性テープ、コイルばね、板ばね、または導電性エラストマーのうちの少なくとも1つを含む、請求項1〜9のいずれか一項に記載の装置。
- 前記接続部分が、前記別個のデバイスと機械的に嵌合するように構成されている、請求項1〜10のいずれか一項に記載の装置。
- 前記別個のデバイスが、分析物データを測定するように構成された電子ユニットである、請求項1〜11のいずれか一項に記載の装置。
- 前記別個のデバイスが、製造ステーションの構成要素である、請求項1〜12のいずれか一項に記載の装置。
- 前記製造ステーションが、ポテンシオスタット測定、浸漬プロセス、硬化プロセス、較正プロセス、または感度測定のうちの少なくとも1つを行うように構成されている、請求項13に記載の装置。
- 前記製造ステーションが、較正ステーションであって、前記センサと前記較正ステーションとの間の電気接続の確立を解除し、前記センサキャリアの前記接続部分を介して、前記センサと少なくとも1つの試験ステーションとの間の電気接続を確立するように構成されている、較正ステーション、を備える、請求項13に記載の装置。
- 前記中間本体が、前記中間本体の基板に対する前記分析物センサの位置および空間的配向を制御するように構成されたデータム構造をさらに備える、請求項1〜15のいずれか一項に記載の装置。
- 前記第1の電極が、前記第2の電極内に同軸に位置付けられている、請求項1〜16のいずれか一項に記載の装置。
- 前記第1の電気接点および前記第2の電気接点が、前記センサの長手方向軸に沿って長手方向に整列および離間している、請求項17に記載の装置。
- 前記第1の電極および前記第2の電極が、可撓性平面基板に固定されている、請求項1〜16のいずれか一項に記載の装置。
- 前記第1の導電性接点および前記第2の導電性接点が、前記可撓性平面基板に固定されている、請求項19に記載の装置。
- 前記第1の導電性接点および前記第2の導電性接点が、導電性接着剤で前記中間本体に固定されている、請求項1〜20のいずれか一項に記載の装置。
- 前記第1の導電性接点および前記第2の導電性接点が、異方性導電フィルムで前記中間本体に固定されている、請求項1〜21のいずれか一項に記載の装置。
- 事前接続された分析物センサのアレイであって、
基板と、
前記基板上に配置された第1の複数の電気接点と、
前記基板上に配置された第2の複数の電気接点と、
前記基板上に配置された複数の分析物センサと、を備え、前記複数の分析物センサの各々が、
前記基板上の前記第1の複数の電気接点のうちの対応する1つに結合された第1のセンサ電気接点と、
前記基板上の前記第2の複数の電気接点のうちの対応する1つに結合された第2のセンサ電気接点と、を備える、アレイ。 - 前記第1の複数の電気接点が、前記基板に沿って整列している、請求項23に記載のアレイ。
- 前記第1の複数の電気接点が、露出した接点表面から形成されている、請求項23または24に記載のアレイ。
- 前記第2の複数の電気接点が、前記基板に沿って整列している、請求項23〜25のいずれか一項に記載のアレイ。
- 前記第2の複数の電気接点が、露出した接点表面から形成されている、請求項23〜26のいずれか一項に記載のアレイ。
- 前記第1および第2の複数の電気接点が、別個のデバイスと接続するように構成されている、請求項23〜27のいずれか一項に記載のアレイ。
- 前記別個のデバイスが、製造ステーションの構成要素である、請求項28に記載のアレイ。
- 前記基板が、前記基板の複数のセンサキャリアへの個片化を容易にするように構成された少なくとも1つの個片化機構を備え、前記複数のセンサキャリアの各々が、前記分析物センサのうちの個々の1つに取り付けられている、請求項23〜29のいずれか一項に記載のアレイ。
- 前記基板上に配置された複数の識別子をさらに備える、請求項23〜30のいずれか一項に記載のアレイ。
- 前記基板が、細長い寸法を備え、前記複数の分析物センサが、前記細長い寸法に直交する方向において、前記基板の縁部を越えて延在する、請求項23〜31のいずれか一項に記載のアレイ。
- 前記細長い寸法において、前記基板の対向する縁部に沿っているフィードガイドストリップをさらに備える、請求項32に記載のアレイ。
- 前記基板が、リール上に巻くように構成された可撓性基板を備える、請求項23〜33のいずれか一項に記載のアレイ。
- 前記フィードガイドストリップが、前記基板から取り外し可能である、請求項33に記載のアレイ。
- 前記基板が、前記複数の分析物センサの位置および配向を制御する複数のデータム機構を有する成形熱可塑性樹脂を備え、前記第1の複数の電気接点および前記第2の複数の電気接点が各々、前記成形熱可塑性樹脂に埋め込まれた導電性トレースを備える、請求項23〜35のいずれか一項に記載のアレイ。
- 前記アレイに結合された第1のデータム構造であって、少なくとも1つの分析物センサを位置付けるように構成された、第1のデータム構造、をさらに備える、請求項23〜36のいずれか一項に記載のアレイ。
- 前記第1のデータム構造が、前記第1のデータム構造の複数の第2のデータム構造への個片化を容易にするように構成された少なくとも1つの個片化機構を含み、前記複数の第2のデータム構造の各々が、前記基板によって形成された複数のセンサキャリアのうちの対応する1つに結合されている、請求項37に記載のアレイ。
- 前記基板が、前記複数の分析物センサについて少なくともポテンシオスタット測定を実行するように構成された処理回路を含む、請求項23〜38のいずれか一項に記載のアレイ。
- 前記分析物センサの識別子とともに前記分析物センサの各々に関連するデータを送受信するように前記処理回路によって動作可能な通信回路をさらに備える、請求項39に記載のアレイ。
- 前記アレイが、1つ以上のストリップを備える、請求項23に記載のアレイ。
- 方法であって、
事前接続された分析物センサを提供することであって、前記事前接続された分析物センサが、
中間本体と、
前記中間本体に恒久的に取り付けられた分析物センサと、
前記中間本体に結合された識別子と、を備える、提供することと、
前記分析物センサを製造ステーションの処理回路に、前記中間本体を前記製造ステーションの対応する機構に結合することにより、通信可能に結合することと、
前記製造ステーションの前記処理回路を動作させて、前記事前接続された分析物センサと通信することと、を含む、方法。 - 前記処理回路を動作させることが、前記分析物センサから信号を取得することを含む、請求項42に記載の方法。
- 前記処理回路を動作させることが、前記製造ステーションの電気、光学、赤外線、または無線周波数リーダを動作させて前記識別子を取得することを含む、請求項42または43に記載の方法。
- 前記製造ステーションの前記処理回路を用いてかつ前記識別子に関連して、前記信号に対応するセンサデータを格納することをさらに含む、請求項43に記載の方法。
- 前記識別子が、前記分析物センサ、前記分析物センサの較正データ、および前記分析物センサの履歴のうちのいずれか1つ以上を識別する、請求項42〜45のいずれか一項に記載の方法。
- 前記信号が、グルコース感度信号を含む、請求項43〜46のいずれか一項に記載の方法。
- 前記製造ステーションから前記中間本体を取り外すことと、前記中間本体をウェアラブルデバイスの対応する機構に結合することにより、前記分析物センサをウェアラブルデバイスの処理回路に通信可能に結合することと、をさらに含む、請求項42〜47のいずれか一項に記載の方法。
- 前記分析物センサが、導電性接着剤で前記中間本体に恒久的に取り付けられている、請求項42〜48のいずれか一項に記載の方法。
- 前記分析物センサが、異方性導電フィルムで前記中間本体に恒久的に取り付けられている、請求項42〜48のいずれか一項に記載の方法。
- 前記ウェアラブルデバイスの前記処理回路を用いて前記分析物センサから生体内測定データを取得することをさらに含む、請求項48に記載の方法。
- ウェアラブルデバイスであって、
ハウジングと、
分析物センサ信号を処理するように構成された電子回路であって、前記ハウジング内に封入されている、電子回路と、
前記ハウジングの外側に位置付けられた遠位部分を有する分析物センサと、
前記分析物センサの近位部分とエレクトロニクスとの両方への電気接続を有する中間本体と、を備え、前記中間本体と前記分析物センサの前記近位部分との間の前記電気接続が、前記ハウジングの外部にある、ウェアラブルデバイス。 - 前記中間本体が、前記ハウジングの外面に隣接して位置付けられている、請求項52に記載のデバイス。
- 前記エレクトロニクスと前記中間本体との両方に結合された電気接点を備える、請求項52または53のいずれか一項に記載のデバイス。
- 前記中間本体が、導電性エポキシで前記電気接点に電気的に接続されている、請求項54に記載のデバイス。
- 前記中間本体が、異方性導電フィルムで前記電気接点に電気的に接続されている、請求項54に記載のデバイス。
- 前記中間本体が封止されている、請求項52〜56のいずれか一項に記載のデバイス。
- 前記電気接点が、前記ハウジングを通って延在する、請求項54〜57のいずれか一項に記載のデバイス。
- 前記分析物センサが、被検体への経皮的埋め込みのために構成された遠位部分と、前記中間本体に電気的に接続するために構成された近位部分と、を有する細長い本体として形成されている、請求項52〜58のいずれか一項に記載のデバイス。
- 前記中間本体が、前記ハウジングの前記外面上の凹部内に位置付けられている、請求項52〜59のいずれか一項に記載のデバイス。
- 電気接点が、前記凹部内の前記ハウジングを通って延在し、前記ハウジング内に封入された前記電子回路に前記中間本体を電気的に結合する、請求項60に記載のデバイス。
- 前記中間本体が、前記凹部内でポリマーで覆われている、請求項60または61のいずれか一項に記載のデバイス。
- 前記分析物センサの前記遠位部分が、前記ハウジングを通って開口部から離れて延在する、請求項52〜62のいずれか一項に記載のデバイス。
- 前記電子回路が、ポテンシオスタットを備える、請求項52〜63のいずれか一項に記載のデバイス。
- 前記電子回路が、無線送信部を備える、請求項52〜64のいずれか一項に記載のデバイス。
- 事前接続された分析物センサを作成する方法であって、
細長い導体の近位部分を中間本体の導電性部分に機械的および電気的に接続することと、
接続後、前記細長い導体の遠位部分をポリマー膜でコーティングして、前記細長い導体の前記遠位部分における分析物検出のための電気化学反応をサポートするように構成された作用電極領域を有する分析物センサを形成することと、を含む、方法。 - 前記分析物センサを試験することであって、前記中間本体を試験ステーションに電気的に結合することを含む、試験することをさらに含む、請求項66に記載の方法。
- 前記分析物センサを較正することであって、前記中間本体を試験ステーションに電気的に結合することを含む、較正することをさらに含む、請求項67に記載の方法。
- 前記コーティングが、浸漬コーティングを含む、請求項66〜68のいずれか一項に記載の方法。
- 前記中間本体が、複数の結合された中間本体によって形成されたアレイの一部であり、前記方法が、複数の細長い電極の各々の近位部分を前記アレイの各中間本体の導電性部分に機械的および電気的に接続することをさらに含む、請求項66〜69のいずれか一項に記載の方法。
- 前記アレイの前記中間本体に接続された前記複数の細長い電極の各々の各遠位部分に並行して前記コーティングを行うことを含む、請求項70に記載の方法。
- 前記コーティングの後に前記アレイの前記中間本体のうちの1つ以上を個片化することを含む、請求項71に記載の方法。
- 機械的および電気的に接続することが、導電性ペーストを前記細長い導体および前記中間本体の前記導電性部分に塗布することを含む、請求項66〜72のいずれか一項に記載の方法。
- 機械的および電気的に接続することが、前記細長い導体の前記近位部分と前記中間本体の前記導電性部分との間で異方性導電フィルムを圧縮することを含む、請求項66〜73のいずれか一項に記載の方法。
- 前記接続することが、前記コーティングから遠隔の場所で行われる、請求項66〜74のいずれか一項に記載の方法。
- 前記コーティング、前記試験、および前記較正がすべて、前記接続することから遠隔の場所で行われる、請求項75に記載の方法。
- 皮膚上ウェアラブルデバイスを作成する方法であって、
ハウジングの内容積内に電子回路を組み込むことであって、前記電子回路が、(1)分析物センサの作用電極での被験体の皮膚の下での電気化学反応から生成される信号を検出するために、かつ(2)別個のデバイスで処理および/または表示するために前記ハウジングの外側で検出された信号から導出されるデータを無線で送信するために、構成されている、組み込むことと、
前記電子回路を前記ハウジングの前記内容積内に組み込んだ後に、前記分析物センサの近位部分を、前記電子回路に結合された外部電気インターフェースに取り付けて、前記電子回路が前記分析物センサに接続されて前記ハウジングを開かずにそこから信号を受信するようにすることと、を含む方法。 - 前記分析物センサの前記近位部分を取り付けた後に、前記インターフェースを封止することを含む、請求項77に記載の方法。
- 前記取り付けの前に、機能について前記電子回路を試験することを含む、請求項77または78に記載の方法。
- 前記取り付けの前に、機能について前記分析物センサを試験することを含む、請求項77〜79のいずれか一項に記載の方法。
- 前記組み込むことが、前記取り付けることから遠隔の場所で行われる、請求項77〜80のいずれか一項に記載の方法。
- 中間本体を前記分析物センサの前記近位部分に結合することを含み、前記取り付けることが、前記中間本体を前記外部電気インターフェースに取り付けることを含む、請求項77〜81のいずれか一項に記載の方法。
- 前記取り付けの前に、前記中間本体を使用して、前記作用電極上で少なくとも1つの製造または試験手順を実施することを含む、請求項82に記載の方法。
- 前記実施することが、前記分析物センサの前記作用電極をコーティングすることを含む、請求項82に記載の方法。
- 前記結合することが第1の場所で行われ、前記組み込むことが第2の場所で行われ、前記実施することが第3の場所で行われ、前記第1、第2、および第3の場所が互いに遠隔にある、請求項83または84のいずれか一項に記載の方法。
- 前記取り付けることが、異方性導電フィルムを用いて行われる、請求項77〜85のいずれか一項に記載の方法。
- 前記結合することが、異方性導電フィルムを用いて行われる、請求項77〜86のいずれか一項に記載の方法。
- 前記作用電極を被検体に埋め込むために、挿入器を前記ハウジングに取り付けることを含む、請求項77〜87のいずれか一項に記載の方法。
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